OraQuick Rapid Home HIV-1/2 Antibody Test
OraSure Technologies, Inc.

Solution Overview & Benefits
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes.
The OraQuick test provides the following features:
- Provides results in 20 minutes, enabling patients to learn their status in a single visit and allows HIV positive patients to be connected to care immediately.
- Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Ideal for both clinical and non-clinical settings.
- Greater than 99% agreement with confirmatory Western blot.
- CLIA-waived for oral fluid, fingerstick and venipuncture whole blood and offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics.
- Offers patients accurate HIV testing without the need for blood or needles. Pain-free testing with oral fluid means more people get screened, more HIV positive patients are connected to care and fewer people are exposed.
History & Development
The OraQuick Rapid Home HIV-1/2 Antibody Test was developed by OraSure Technologies to provide a simple, accessible, and rapid way for individuals to test for HIV at home. Originally designed for healthcare settings, the first OraQuick test was approved by the FDA in 2002 for professional use, offering an alternative to traditional lab-based testing.
To address the stigma and barriers associated with HIV testing, OraSure adapted the test for consumer use, resulting in the FDA’s approval of the over-the-counter version in 2012. This made it the first at-home HIV test available in the United States. The OraQuick Home Test uses oral fluid to detect antibodies, and provides results within 20 minutes, empowering individuals to know their status in privacy, thereby promoting earlier diagnosis and treatment, ultimately helping to curb the spread of HIV.
Availability
- Publicly available: yes
- Countries where available: Worldwide
- Price range (USD): 1 to 20 USD
- Available online: yes
Specifications
- Test Type: Oral fluid-based HIV-1/2 antibody test.
- Sample Collection: Uses an oral swab to collect fluid from the gums; no blood required.
- Detection: Detects antibodies to both HIV-1 and HIV-2.
- Result Time: Provides results in 20-40 minutes.
- Accuracy:
- Sensitivity (ability to correctly identify HIV-positive individuals): Greater than 99%.
- Specificity (ability to correctly identify HIV-negative individuals): Greater than 99%.
- Ease of Use: Designed for at-home use, with clear instructions provided in the kit.
- Packaging: Comes with a test stick, vial of test fluid, and detailed instructions for proper use.
- Shelf Life: Typically has a shelf life of 18-24 months when stored at room temperature.
- Regulatory Approval: FDA-approved for over-the-counter use in the United States.
Additional Information
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